Aortic Coarctation, Cardiac Output, Low
Conditions
Keywords
PRAM, Near-Infrared Spectroscopy, Cardiac Index, Pediatric Cardiac Surgery, Lactate, Aortic Coarctation
Brief summary
This prospective observational study aims to evaluate the correlation between cardiac index measured by the MostCare™ system (Pressure Recording Analytical Method, PRAM) and cerebral/renal regional oxygen saturation measured by near-infrared spectroscopy (NIRS) and arterial lactate levels in neonates and infants (body weight 2.5-3.5 kg, age 0-3 months) undergoing surgical repair of aortic coarctation. Measurements will be recorded at four intraoperative time points: after anesthesia induction, before aortic cross-clamp, 3 minutes after cross-clamp release, and at end of surgery. No additional intervention beyond standard anesthesia and surgical care will be applied.
Detailed description
Low cardiac output syndrome (LCOS) is a major determinant of postoperative morbidity and mortality in neonatal cardiac surgery, particularly in lesions affecting systemic circulation such as aortic coarctation. Reliable intraoperative assessment of cardiac output is therefore critical in this patient population. The MostCare™ system uses the Pressure Recording Analytical Method (PRAM) to provide real-time, calibration-free cardiac index (CI) measurement derived solely from the arterial pressure waveform. Previous studies in infants have demonstrated good correlation between PRAM and echocardiography; however, data in neonates weighing less than 3.5 kg remain very limited. Near-infrared spectroscopy (NIRS) allows non-invasive monitoring of regional cerebral and renal oxygen saturation (rSO2), serving as an early indicator of tissue oxygenation. Arterial lactate is a biochemical marker of cellular hypoperfusion and is strongly associated with postoperative outcomes. In this study, CI (MostCare™), cerebral and renal NIRS (INVOS™ oximeter), and arterial lactate will be simultaneously recorded at four intraoperative time points in neonates and infants undergoing aortic coarctation repair. The primary aim is to assess the correlation between PRAM-derived CI and cerebral NIRS. Secondary aims include the correlation between CI and renal NIRS, and between CI and arterial lactate levels.
Interventions
DEVICEMostCare (PRAM)
Real-time, calibration-free cardiac index monitoring via arterial pressure waveform analysis using the MostCare™ system. Used as part of routine intraoperative hemodynamic monitoring.
Non-invasive monitoring of regional cerebral and renal oxygen saturation (rSO2) using the INVOS™ oximeter as part of standard intraoperative care.
PROCEDUREArterial Blood Gas with Lactate
Arterial blood gas sampling for lactate measurement at four intraoperative time points as part of routine clinical monitoring.
Sponsors
Konya City Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 3 Months
Healthy volunteers
No
Inclusion criteria
* Neonates and infants planned for surgical repair of aortic coarctation * Body weight between 2.5 and 3.5 kg * Postnatal age between 0 and 3 months * Considered hemodynamically stable for anesthesia and surgery * Written informed consent obtained from legal guardians
Exclusion criteria
* Severe multiorgan dysfunction * Additional major congenital heart defect (e.g., Tetralogy of Fallot, Transposition of Great Arteries, Hypoplastic Left Heart Syndrome) * Surgery requiring cardiopulmonary bypass * Preoperative metabolic acidosis or sepsis * Inability to obtain informed consent from legal guardians
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Correlation between PRAM-derived Cardiac Index and Cerebral NIRS (rSO2c) | Intraoperative (at 4 time points: after anesthesia induction, before aortic cross-clamp, 3 minutes after cross-clamp release, and at end of surgery) | Pearson or Spearman correlation coefficient between cardiac index (CI, L/min/m²) measured by MostCare™ (PRAM method) and cerebral regional oxygen saturation (rSO2c, %) measured by INVOS™ oximeter at four intraoperative time points. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Correlation between PRAM-derived Cardiac Index and Renal NIRS (rSO2r) | Intraoperative (at 4 time points: after anesthesia induction, before aortic cross-clamp, 3 minutes after cross-clamp release, and at end of surgery) | Pearson or Spearman correlation coefficient between cardiac index (CI, L/min/m²) and renal regional oxygen saturation (rSO2r, %) at four intraoperative time points. |
| Correlation between PRAM-derived Cardiac Index and Arterial Lactate Level | Intraoperative (at 4 time points: after anesthesia induction, before aortic cross-clamp, 3 minutes after cross-clamp release, and at end of surgery) | Pearson or Spearman correlation coefficient between cardiac index (CI, L/min/m²) and arterial lactate level (mmol/L) at four intraoperative time points. |
Countries
Turkey (Türkiye)
Contacts
CONTACTBedia Mine Hanedan, MD
PRINCIPAL_INVESTIGATORBedia Mine Hanedan, MD
Konya City Hospital
Outcome results
None listed